510(k) · Cleared
ClearedUltratemp Firm, Fast and Regular Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultradent Products, Inc. · EMA Cement, Dental
Cleared on Apr 11, 2008 as substantially equivalent to K994261 (Ultradent Products, Inc., 2000) after a 24-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Apr 11, 2008
- Review
- 24 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K994261 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK994261 Ultratemp Temporary Polycarboxylate CementUltradent Products, Inc. · 2000
- This deviceK080768 Ultratemp Firm, Fast and Regular SetUltradent Products, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK211237 UltraTemp Rez IIUltradent Products, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK261937 PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K994261 | Ultratemp Temporary Polycarboxylate Cement | Ultradent Products, Inc. | 2000 | — |
| 0 (this device) | K080768 | Ultratemp Firm, Fast and Regular Set | Ultradent Products, Inc. | 2008 | — |
| +1 | K211237 | UltraTemp Rez II | Ultradent Products, Inc. | 2021 | — |
| +2 | K261937 | PacTemp Automix NE | The Belport Company Inc., DBA Gingi-Pak | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EMA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K994261 | Ultratemp Temporary Polycarboxylate CementSummary page 1…n: II Classification Product Code: EMVA Legally Marketed Predicate Devices to Which Equivalence IsClaimed The predicate device isUltraTemp (K994261) This device ismanufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, Utah 84095. Produc… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211237 | UltraTemp Rez II | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K211237 (Ultradent Products, Inc., 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
What is it indicated for?
UltraTemp Firm, Fast and Regular is a non-eugenol temporary cement indicated for interim cementation of inlays, onlays, crowns and bridges. It is methacrylate based and does not negatively affect resin bonding. Being water soluble until set, it cleans up easily.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080768: Ultratemp Firm, Fast and Regular Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080768
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026